More Safety Concerns for Byetta
Byetta, a drug made by Amylin Pharmaceuticals to treat type 2 diabetes, is undergoing new safety studies per a request from the Food & Drug Administration (FDA). The studies are looking at Byetta’s possible association with inflammation of the pancreas, acute renal failure and thyroid neoplasms (usually cancer of the thyroid).
According to a Reuters report, the FDA is requiring the drug maker to conduct the following studies:
*A epidemiological study on acute pancreatitis in Byetta versus non-Byetta patients
*Eidemiologic queries on pancreatic cancer and thyroid neoplasm in Byetta versus patients taking certain alternative therapies
*A clinical trial to see whether Byetta may increase the risk of gall bladder gallstones and therefore pancreatitis
The FDA’s request for new Byetta safety studies was made public yesterday by Citigroup analyst in a note to investors. According to the note, a letter the FDA sent Amylin in October approving the expanded used of Byetta had requested the studies.
